Phase II study of induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantatio
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000010401
- Lead Sponsor
- Kanagawa Clinical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 37
Not provided
1)Women in pregnancy or lactation; women who can not or intend to use appropriate contraceptive methods 2)Active and advanced cancer 3)steroid administration equivalent to 10mg prednisolone for other disease 4)psychiatric disease or psychological symptom 5)Positive for HBs antigen or able to detect HBV DNA 6)Positive for HCV antibody 7)Positive for HIV antibody 8)poorly controlled diabetes mellitus 9)poorly controlled hypertension 10)Cardiac amyloidosis 11)Angina; acute myocardial infarction last 6 months; heart failure or arrythmia that needs treatment 12)Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or pleural effusion that allows aspiration 13)Peripheral neuropathy Grade >=2; painful peripheral neuropathy 14)Severe drug allergy 15)The patient judged inappropriate to participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete response rate
- Secondary Outcome Measures
Name Time Method overall response rate, progression free survival, overall survival, incidence rate of adverse events, rate of complete treatment